About the role
Senior Medical Device Engineer
Location: Lexington, Massachusetts
Our client is a global leader in the pharmaceutical sector, dedicated to advancing patient care through innovative medical devices and combination products. We are seeking an experienced Senior Staff Engineer to join their team in Lexington. This role is ideal for a technical leader who enjoys solving complex engineering challenges and mentoring others within a regulated environment.
As a key member of the engineering team, you will act as a consultant to management and an external representative for major technical matters. You will lead the design, testing, and operational oversight of medical equipment, ensuring all products meet the highest standards for safety, performance, and reliability. This position offers a high degree of autonomy and the opportunity to influence the development of new industry concepts and standards.
Key Responsibilities
Oversee engineering operations for medical devices and combination products from development through commercialization.
Lead advanced mechanical engineering tasks, including CAD fixture design using SolidWorks, 3D printing, and CT scan data analysis.
Create and maintain technical documentation, protocols, and guidance to ensure standardization and high quality across all programs.
Manage the validation of test methods and equipment in compliance with GxP and international medical device regulations.
Collaborate with cross functional teams, including Quality, Regulatory Affairs, and Drug Product Development, to align on device qualification strategies.
Supervise relationships with external partners such as CROs and CMOs, providing technical support and investigating root causes for deviations.
Mentor junior staff members to foster professional growth and technical excellence within the department.
Required Qualifications
Bachelor of Science in Mechanical, Chemical, Biomedical, or Materials Engineering with at least 8 years of industry experience. Candidates with a Master degree and 6 years of experience or a PhD are also encouraged to apply.
Strong background in the development of regulated combination products under ISO 13485, ISO 14791, and 21 CFR 820 Design Controls.
Expertise in injection molding, product design, and statistical evaluations.
Demonstrated ability to author and review complex technical reports and regulatory submission documents for BLA, NDA, or MAA filings.
Exceptional communication skills and the ability to influence stakeholders across different business units.
Experience with test system validation and Design for Six Sigma certification is highly preferred.
Working Conditions
This role requires working in controlled manufacturing environments which may involve specific gowning procedures, protective equipment, and occasional exposure to cold or wet conditions. Applicants should be flexible regarding shift schedules if needed to support project milestones.
Compensation
The estimated base salary range for this position is 137,000 to 215,270 USD annually. Final offers are determined based on the candidates specific experience, educational background, and technical certifications. Our client also offers a comprehensive benefits package.
Our client is an equal opportunity employer committed to a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or any other protected characteristic.
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